Countries that are geographically related, and of similar economic status, can at times be observed to also adopt certain policies and procedures in close proximity. TWN and KOR are two such countries that have followed similar timelines, shown in Figure 1.
Both countries experienced significant political change in the late 1980s – and although their subsequent steps are not perfectly aligned, they tended to follow the similar policy development approach of universal coverage, followed by budgetary short-fall, and then establishment of a positive list and HTA process to defend that list.
Figure 1: Policy evolution KOR and TWN.
So, it should not be surprising that the more granular details of each country’s respective HTA body also follow similar approaches. To understand the correlation of positive / negative decisions on high-value, specialty therapeutics, we explored whether this similarity between healthcare policy development transferred to actual new product reimbursement decisions.
Figure 2: HTA decisions from TWN and KOR between 2012 and Jul 2016 in chronological order.
HTA decisions from TWN and KOR between 2012 and Jul 2016, are depicted in Figure 2, which shows the respective HTA authority’s decision (positive or negative) on all high-value, specialty therapeutics launched in both markets during this period. The products are arranged in chronological order based on the timing of the decision from the second of the two HTA authorities. It appears that 70-80% of the decisions between the two markets match – that is to say that if KOR gave a positive reimbursement decision, TWN tended to do so as well, with the same being true for negative decisions. This implies that one market can, more often than not, be a predictor of the other. Interestingly, it also appears that the diverging decisions are clustered in specific moments in time.
HTA processes in TWN and KOR have been developed over time, and should not solely be defined based on legislation, but rather on the actual reviews and decisions released for new products. This is because consistency in how these methods are employed in the real world is often imperfect. Indeed, in some countries, the fact that an economically similar and regionally related country has already reviewed a new drug and made a certain decision based on logical rationale, there is likely to be a predisposition to adopt a similar decision. This does not mean that the rationale or methods employed to support that rationale will be the same – simply that access to the drug in question can be more defendable if an analogous environment has already made that decision.
Hence, it is not uncommon for HTA decisions for new products to mirror each other, particularly among countries in the same region and with similar states of economic development. It is therefore unsurprising that KOR and TWN already largely reflect one another’s access decisions – and that as these systems become more established, their decisions have a tendency towards convergence.
It is also interesting to note that both ZELBORAFTM (NVS, vemurafenib) and JARDIANCETM (LLY / BI, empagliflozin) are products likely to have a significant budget impact. During the time of these reviews by each country’s HTA authority, the political climate was heating up with elections. The question therefore arises as to whether the diverging decisions could be due to major political events in one of the two countries.
In November 2014, TWN had a local election. During that period, ZELBORAFTM, a treatment for metastatic melanoma, was not reimbursed in KOR; however, it was also assessed in TWN, and subsequently reimbursed. Similarly, in April 2016, KOR had a general election, and JARDIANCETM, a treatment for T2DM, was reimbursed in KOR. However, in TWN, it did not receive reimbursement coverage in TWN when it was assessed a few months earlier.
On the other hand, the need for ethnobridging of clinical trials in KOR suggests that the local health authorities believe that, in certain cases, their own patient population has very unique characteristics that may cause differences in how effective or safe a new product may be relative to other countries. It is plausible that the contrasting decisions could equally well have been caused by the perception of different needs of the patients in the two markets.
The reality is that HTA decisions are not driven by a single rationale – not another country’s HTA decision, not the local political environment, and not the unique nature of local patient populations. None of these can drive a decision alone, but a composite of them very well could do so. As such, all aspects of both the product’s dossier and environmental issues should be taken into account when planning for submission and negotiation at the country level.